Voclosporin Food Effect and Single Oral Ascending Dose Pharmacokinetic and Pharmacodynamic Studies in Healthy Human Subjects

Voclosporin (VCS) is a novel calcineurin (CN) inhibitor intended for prevention of organ graft rejection and treatment of lupus nephritis. These studies evaluated the single ascending dose pharmacokinetics (PK) and pharmacodynamics (PD, CN activity) of VCS and the effect of food. VCS was administere...

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Veröffentlicht in:	Journal of clinical pharmacology 2013-08, Vol.53 (8), p.819-826
Hauptverfasser:	Mayo, Patrick R., Huizinga, Robert B., Ling, Spencer Y., Freitag, Derrick G., Aspeslet, Launa J., Foster, Robert T.
Format:	Artikel
Sprache:	eng
Schlagworte:	Adolescent Adult calcineurin inhibitor Calcineurin Inhibitors clinical pharmacology Cross-Over Studies Cyclosporine - administration & dosage Cyclosporine - adverse effects Cyclosporine - pharmacokinetics Diet, Fat-Restricted Diet, High-Fat Double-Blind Method Enzyme Inhibitors - administration & dosage Enzyme Inhibitors - adverse effects Enzyme Inhibitors - pharmacokinetics Fasting - metabolism Female food effect Food-Drug Interactions Healthy Volunteers Humans Male Middle Aged pharmacodynamics pharmacokinetics voclosporin Young Adult
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